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Oropharyngeal Neoplasms clinical trials

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NCT ID: NCT06088381 Recruiting - Clinical trials for Head and Neck Cancer

Selective Adjuvant Therapy for HPV-mediated Oropharynx SCCs Based on Residual Circulating Tumor DNA Levels (SAVAL)

SAVAL
Start date: March 7, 2024
Phase: Phase 2
Study type: Interventional

Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have favorable outcomes and how well they do depends on the specific details about the patient and their cancer. How well they do isn't as related to the kinds of treatment they get. However, there are significant side effects for the various types of treatments they may get. Because these patients generally have favorable outcomes no matter the kind of treatment, reducing side effects should be a priority when choosing their treatment. The goal of this clinical research study is to evaluate whether a new blood test called a Circulating Tumor DNA test (ctDNA test) can decrease the number of people that require radiation after surgery. This blood test is often elevated in people when they are diagnosed with head and neck cancer. There are studies that show that cancer most often returns when this blood test is positive after treatment. This study will test patients' blood before and after surgery. In cases where the test is negative after surgery, people on the study will not receive radiation unless they are considered high risk based on surgery findings. The hope is that radiation and its potential side effects can be limited to only people that need the treatment.

NCT ID: NCT06016699 Recruiting - Clinical trials for Head and Neck Cancer

Immunological Function After Radiation With Either Proton or Photon Therapy

PRO-IMMUNO
Start date: September 23, 2021
Phase:
Study type: Observational [Patient Registry]

This is a pilot prospective observational cohort study, comprising patients with head and neck cancer (HNSCC) treated with standard of care definitive (chemo)radiation either with photons or protons. Patients will be assigned for protons or photons based on the guidelines of the National Indication Protocol for Proton therapy of the Netherlands. Immunological function will be evaluated by the collection of peripheral blood mononuclear cells (PBMCs). Blood samples will be collected at baseline, during (chemo)radiation (end of week 3 and/or before week 4 of treatment) and after completion of (chemo)radiation (week 9, week 12, week 20, week 34 and week 60, respectively 1 week, 5 weeks, 3 months, 6 months and 12 months after completion of (chemo)radiation). To quantify immunological function, PBMCs collected during (chemo)radiation and after (chemo)radiation will be compared with that before (chemo)radiation (week 0), using IFN-γ-ELISPOT to screen for the presence of antigen-specific T-cell responses. Furthermore, flow cytometry panels will be used to determine global changes in immune cell proficiency. Histological evaluation will take place at baseline and week 3 to examine changes in immune infiltration within tumour tissue during proton versus photon (chemo)radiation. This biopsy part of the study is optional for the patient. Archival tissue from the biopsy that was taken at diagnosis will be used for the baseline assessments. Biopsy at week 3 week will be taken for all patients who agree to participate in this optional part of the study.

NCT ID: NCT06007092 Recruiting - Clinical trials for Head and Neck Carcinoma

Therapeutic Vaccine in Patients With Human Papillomavirus HPV-positive Oropharyngeal Cancer

HPVDCVax
Start date: July 31, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a multicentric double-blind placebo-controlled dose escalation trial of a CD40HVac vaccine (humanized anti-CD40 mAb fused to HPV16 E6/E7 oncoproteins) adjuvanted with poly-ICLC (Hiltonol) in patients with HPV16 oropharyngeal carcinoma with no evidence of residual or recurrent disease after surgery and/or radiochemotherapy. The primary objective is to determine the recommended phase 2 dose (RP2D) of a poly-ICLC(Hiltonol)-adjuvanted CD40HVac vaccine according to the safety and the capacity to elicit immune responses of different doses Two dose levels of poly-ICLC-adjuvanted CD40.HVac will be explored - 1st dose level: CD40.HVac 1.0 mg, with 1.0 mg poly-ICLC - 2nd dose level: CD40.HVac 3.0 mg, with 1.0 mg poly-ICLC The safety data will be reviewed by an IDSMB that will give recommendations.

NCT ID: NCT05996523 Recruiting - Clinical trials for Oropharyngeal Squamous Cell Carcinoma (SCC)

Phase II Trial of Immunotherapeutic HPV Vaccine PRGN-2009 With Pembrolizumab Before Standard Treatment in Subjects With Newly Diagnosed HPV-Associated Oropharyngeal Cancer

Start date: November 7, 2023
Phase: Phase 2
Study type: Interventional

Background: Cancers in and around the mouth associated with human papilloma virus (HPV) are common. Two treatments (the drug pembrolizumab and the HPV vaccine PRGN-2009) have been shown to work well when used individually against these cancers. Researchers want to find out if they might work better when used together. Objective: To test pembrolizumab combined with PRGN-2009 in people with HPV-positive cancers in and around the mouth. Eligibility: Adults aged 18 and older newly diagnosed with HPV-positive cancers in and around the mouth. Design: Participants will be screened. They will have a physical exam with blood tests. They will have imaging scans. They may need to have a biopsy: A sample of tissue will be taken from the tumor. PRGN-2009 is given as an injection under the skin. Pembrolizumab is given through a tube attached to a needle inserted into a vein in the arm. Participants will have at least 3 clinic visits: At the first, they will receive both the drug and the vaccine; 15 days later, they will receive a second shot of the vaccine. At the third visit, about 1 week after the second, they will have follow-up tests. During these visits, participants will give samples of blood, urine, and saliva. Imaging scans and biopsies will be repeated. They will have tests of their heart function. Participants may opt to return for another follow-up visit about 1 month after their second dose of the vaccine. Participants will have follow-up contacts by phone 3 and 6 months after starting the study. The calls will continue once a year for 5 years.

NCT ID: NCT05933889 Recruiting - Cancer Head Neck Clinical Trials

Single and Combined Modality Trans-Oral Robotic Surgery in Early Oropharyngeal Cancer

SCORE
Start date: December 19, 2023
Phase:
Study type: Observational

Multi-centre retrospective observational cohort study with optional exploratory radiomic study (international) and prospective molecular analysis studies (UK only).

NCT ID: NCT05894083 Recruiting - Clinical trials for Oropharyngeal Cancer

A Phase II Study for p16+ Oropharyngeal Cancer PerSonalized De-escalation Treatment at University of MIchigan (CuSToMIze)

Start date: April 27, 2023
Phase: Phase 2
Study type: Interventional

Single center, non-randomized Phase II study enrolling Stage I-II p16+ oropharyngeal cancer patients to one of two de-escalation treatment paradigms: (1) receive surgery followed by observation or risk-adjusted adjuvant radiation (+/-chemo), or (2) individualized adaptive definitive chemoradiation (CRT).

NCT ID: NCT05880797 Recruiting - Clinical trials for Human Papilloma Virus

Multidimensional and Multimodal Profiling of Oropharyngeal Carcinoma

Start date: July 7, 2023
Phase:
Study type: Observational

The purpose of this study is to better understand the natural history of oropharyngeal carcinoma (OPC), with or without an association with the human papilloma virus (HPV). For this study, the investigators plan to collect blood from OPC patients prior to treatment and at six subsequent time points.

NCT ID: NCT05862792 Recruiting - Post Operative Pain Clinical Trials

Liposomal Bupivacaine and Transoral Robotic Surgery

Start date: June 1, 2023
Phase:
Study type: Observational

This study is for patients with oropharyngeal squamous cell carcinoma. We want to learn more about how we can optimize pain control in patients who undergo transoral robotic surgery (TORS) for oropharyngeal squamous cell carcinoma. Our goal is to determine if a local anesthetic called EXPAREL® (Liposomal Bupivacaine) impacts postsurgical pain and swallow function in patients with oropharyngeal squamous cell carcinoma undergoing TORS. EXPAREL® is an FDA-approved anesthetic drug that provides long-lasting and precise pain relief when injected into the surgical wound. Our study team wants to determine if injecting EXPAREL® into the surgical wound will provide better pain relief and swallow function when compared to patients who do not undergo postoperative EXPAREL® injection. Both options for postoperative pain control are considered standard of care for patients undergoing TORS.

NCT ID: NCT05814549 Recruiting - Clinical trials for Oropharyngeal Cancer

A Study Using Human Papillomavirus (HPV) DNA Testing to Detect HPV-Related Oropharyngeal Cancer (OPC)

Start date: March 31, 2023
Phase:
Study type: Observational

The researchers think that a blood test (NavDx®) may be able to identify cancer early by looking for circulating DNA from Human Papillomavirus/HPV. Circulating DNA are small pieces of genes that are released into the bloodstream. The purpose of this study is to find out whether using this blood test to test for HPV DNA will help detect HPV-related Oropharyngeal Cancer/OPC.

NCT ID: NCT05800574 Recruiting - Oropharynx Cancer Clinical Trials

Lymphoscintigraphy Directed Elective Neck Radiation for p16+ Favorable Risk Oropharynx Cancer

Start date: March 14, 2023
Phase: Phase 2
Study type: Interventional

This is a prospective, phase II, stratified single arm investigation for favorable prognosis in p16+ oropharynx cancer patients with either node negative or malignant neck adenopathy with lymphoscintigraphy mapping confined to the ipsilateral neck.